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Amsco

FDA UDI

Class II (US FDA UDI)

by Corporation Steris Canada

Identity

Trade Name
AMSCO FDA UDI
Generic Name
Surgical instrument washer/disinfector (chemical/thermal) FDA UDI
Device Name
AMSCO 7053HP Washer-Disinfector Steam Heated Unit delivers a validated and cleared process for cleaning reusable da Vinci EndoWrist X/Xi, S/Si, and Single-Site instruments and staplers. FDA UDI
Model / Reference
7053HP FDA UDI
Description
AMSCO 7053HP Washer-Disinfector Steam Heated Unit delivers a validated and cleared process for cleaning reusable da Vinci EndoWrist X/Xi, S/Si, and Single-Site instruments and staplers. FDA UDI

Identifiers

Catalog Number
FH19082 FDA UDI
Primary DI / UDI-DI
00724995176648 FDA UDI
FDA Product Code
MEC FDA UDI
NVE FDA UDI
GMDN Term
Surgical instrument washer/disinfector (chemical/thermal) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6992 FDA UDI
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical instrument washer/disinfector (chemical/thermal)

Amsco by Corporation Steris Canada — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument washer/disinfector (chemical/thermal).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corporation Steris Canada

Sources (1)

  • FDA UDI 814a7f2e-c509-4f74-a111-64cfc6199bea 35 fields · synced Jun 6, 2026